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Mylanta New Tonight Soothing Honey Chamomile

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Active ingredients
  • Dimethicone 80 mg/10 mL
  • Calcium Carbonate 800 mg/10 mL
  • Magnesium Hydroxide 270 mg/10 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
February 1, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 80 mg/10 mL
  • Calcium Carbonate 800 mg/10 mL
  • Magnesium Hydroxide 270 mg/10 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
February 1, 2023
Manufacturer
Infirst Healthcare Inc.
Registration number
part331
NDC root
62372-510
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Mylanta® is a liquid antacid and anti-gas medication designed to provide fast relief from heartburn and acid indigestion, particularly after dinner when many adults experience these symptoms. It features a soothing Honey Chamomile flavor and a non-drowsy formula, making it easy to take.

The active ingredients in Mylanta® include calcium carbonate (which neutralizes stomach acid), magnesium hydroxide (which also helps reduce acidity), and simethicone (which alleviates gas). This calcium-rich formula works quickly to coat the stomach and soothe discomfort, offering a smooth and creamy taste for a pleasant experience.

Uses

If you're experiencing discomfort from heartburn, pressure, or bloating, this medication can help relieve those symptoms. It effectively addresses acid indigestion and a sour stomach, making it a useful option for those times when your stomach feels upset.

Additionally, if you've overindulged in food and drink, this medication can provide relief from that uncomfortable feeling as well. It's designed to help you feel better when your digestive system is acting up.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you can take between 2 teaspoons (tsp) to 4 tsp, which is 1 to 2 doses, between meals or at bedtime, unless your doctor advises otherwise. However, be careful not to exceed 12 tsp (6 doses) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks.

If the patient is a child under 12 years old, it’s important to consult a doctor before administering the medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of certain precautions when using this medication. If you suspect an overdose, you should seek medical help immediately or contact a poison control center at 1-800-222-1222. This ensures you receive the necessary assistance as quickly as possible.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence (which means relying on a substance) associated with this medication mentioned in the provided information. Always follow the guidance of your healthcare provider for safe use.

Side Effects

Before using this medication, it's important to consult your doctor if you have kidney disease or are on a magnesium-restricted diet, as these conditions may affect how the medication works for you. Additionally, if you are currently taking any prescription drugs, be sure to speak with your doctor or pharmacist, as antacids can interact with some medications.

Always prioritize your health by discussing any concerns or existing conditions with your healthcare provider before starting new treatments.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have kidney disease or are on a magnesium-restricted diet. These conditions can affect how the medication works in your body.

If you suspect an overdose, seek emergency medical help immediately or contact a poison control center at 1-800-222-1222. Additionally, if you are currently taking any prescription medications, please talk to your doctor or pharmacist before using this product, as antacids can interact with certain drugs.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of Mylanta Tonight Soothing Honey Chamomile during pregnancy has not been established. There may be potential risks to your fetus, but specific studies or data are not available. Therefore, it is crucial to consult your doctor before using this product.

While there are no specific dosage modifications mentioned for pregnant individuals, seeking medical advice is strongly recommended. Always discuss any medications or products you plan to use during pregnancy with your healthcare provider to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should not use it without consulting a doctor first. For those aged 12 and older, the recommended dosage is between 2 teaspoons to 4 teaspoons (1-2 doses) taken between meals or at bedtime, as directed by a healthcare professional. However, be cautious not to exceed 12 teaspoons (6 doses) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks to ensure safety. Always follow your doctor's guidance when it comes to medication for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some medications, like antacids, can interact with your prescription medications, potentially affecting how well they work or increasing the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking to ensure your treatment is safe and effective. This way, you can avoid any unexpected interactions and get the best possible care.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing, as this can damage the product.

When handling the product, check the tamper-evident seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may not be safe. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 and over being 2 to 4 teaspoons (1-2 doses) between meals or at bedtime, or as directed by your doctor. It's important not to exceed 12 teaspoons (6 doses) in a 24-hour period and to avoid using the maximum dosage for more than 2 weeks. If the patient is under 12 years old, consult a doctor for appropriate guidance.

FAQ

What is Mylanta®?

Mylanta® is a liquid antacid and anti-gas medication designed for fast relief of heartburn, acid indigestion, and gas, with a soothing Honey Chamomile flavor.

What are the active ingredients in Mylanta®?

The active ingredients in Mylanta® are calcium carbonate, magnesium hydroxide, and simethicone.

How should I take Mylanta®?

Adults and children 12 years and over should take 2 to 4 teaspoons (1-2 doses) between meals or at bedtime, but do not exceed 12 teaspoons (6 doses) in 24 hours.

Can children under 12 use Mylanta®?

Children under 12 years should ask a doctor before using Mylanta®.

Are there any warnings for using Mylanta®?

You should ask a doctor before use if you have kidney disease or are on a magnesium-restricted diet, and consult a doctor if you are taking prescription drugs, as antacids may interact with them.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a poison control center immediately at 1-800-222-1222.

Is Mylanta® safe to use during pregnancy?

The safety of Mylanta® during pregnancy has not been established, so it is recommended to consult a healthcare provider before use.

How should I store Mylanta®?

Store Mylanta® between 20-25°C (68-77°F) and do not freeze. Ensure the tamper-evident seal under the cap is intact before use.

Packaging Info

Below are the non-prescription pack sizes of Mylanta New Tonight Soothing Honey Chamomile (calcium carbonate, magnesium hydroxide and simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta New Tonight Soothing Honey Chamomile.
Details

Drug Information (PDF)

This file contains official product information for Mylanta New Tonight Soothing Honey Chamomile, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Mylanta® is a liquid formulation that combines antacid and anti-gas properties. It is presented in a soothing honey chamomile flavor and is available in a volume of 10 FL OZ (296 mL). The active ingredients include calcium carbonate, magnesium hydroxide, and simethicone, contributing to its calcium-rich formula. Mylanta® is paraben-free and offers a smooth, creamy taste. This product is designed for non-drowsy use, allowing administration at any time of the day. Mylanta® is a registered trademark of McNeil Consumer Pharmaceuticals Co. and is manufactured by Infirst Healthcare Inc., located in Westport, CT 06880. Copyright © 2022 Infirst Healthcare Inc.

Uses and Indications

This drug is indicated for the relief of heartburn, pressure and bloating commonly referred to as gas, acid indigestion, sour stomach, and upset stomach associated with these symptoms. It is also indicated for the relief of discomfort resulting from overindulgence in food and drink.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be shaken well before use. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoons (1 to 2 doses) taken between meals, at bedtime, or as directed by a healthcare professional. It is important not to exceed a total of 12 teaspoons (6 doses) within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks.

For children under 12 years of age, it is advised to consult a healthcare professional before administration.

Contraindications

There are no specified contraindications for the use of this product. However, in the event of an overdose, it is imperative to seek medical assistance immediately or contact a poison control center at 1-800-222-1222.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. These conditions may affect the safety and efficacy of the treatment.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Contact a poison control center at 1-800-222-1222 for guidance.

Patients are advised to discontinue use and consult their healthcare provider if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which may necessitate a review of the patient's medication regimen to avoid adverse effects.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to consult a healthcare professional before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet, as these conditions may increase the risk of adverse effects.

Additionally, patients are advised to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which may lead to unforeseen complications or diminished efficacy of the prescribed treatment.

Monitoring for any adverse reactions is essential, and patients should report any unusual symptoms or concerns to their healthcare provider promptly.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with certain prescription medications, which could affect the efficacy of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta New Tonight Soothing Honey Chamomile (calcium carbonate, magnesium hydroxide and simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta New Tonight Soothing Honey Chamomile.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 teaspoons to 4 teaspoons (1-2 doses) between meals or at bedtime, or as directed by a physician. It is important not to exceed 12 teaspoons (6 doses) within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of Mylanta Tonight Soothing Honey Chamomile during pregnancy has not been established. Pregnant patients or those planning to become pregnant are advised to consult a healthcare provider prior to use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

No specific dosage modifications for pregnant individuals are mentioned; nonetheless, it is recommended that medical advice be sought before using this product during pregnancy. Healthcare professionals should encourage women of childbearing potential to discuss their options and any concerns with their healthcare provider to ensure the safety of both the patient and the fetus.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may not need to take special precautions when prescribing this medication to lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a poison control center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should encourage patients to consult with their doctor or pharmacist prior to using this medication if they are currently taking any prescription drugs. Patients should be made aware that antacids may interact with certain prescription medications, and it is essential to ensure their safety and efficacy by discussing all current medications with a healthcare professional.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the printed seal under the cap; the product should not be used if this seal is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20-25°C (68-77°F). It is crucial to avoid freezing the product to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 to 4 teaspoons (1-2 doses) between meals or at bedtime, or as directed by a healthcare professional. Patients should not exceed 12 teaspoons (6 doses) within a 24-hour period and should not use the maximum dosage for more than 2 weeks. For children under 12 years of age, consultation with a doctor is advised before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Mylanta New Tonight Soothing Honey Chamomile, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mylanta New Tonight Soothing Honey Chamomile, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.